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Completed

NCT Number: NCT03679260

Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI >25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.

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Key information

Conditions

Prostate Cancer Body Weight Body Weight Changes Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Weight Loss

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically confirmed prostate adenocarcinoma
  • Most recent biopsy positive for prostate cancer
  • Currently on or starting active surveillance
  • Ability to read, write, and understand English
  • BMI >24 kg/m2
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  • Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer
  • Age > 18 years

Exclusion criteria

  • Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates per day) or vegetarian diet
  • Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
  • Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy)
  • Loss of >10% of body weight within the previous 6 months
  • Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide)
  • If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications)
  • Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge)
  • Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program

Treatment and study plan

Carbohydrate restricted diet

Other

20 grams total carbs/day

Non-restricted diet

Other

Subject follows normal diet

phone counseling with dietitian

Other

Weekly calls with dietitian

Primary outcomes

  1. Mean difference change in proliferative index in prostate cancer patients between carbohydrate restricted diet and non-restricted diet groups from pre-study biopsy (baseline) to 6 months.

    Time frame: 6 months

    Proliferative index is measured by Ki67/apoptosis rate

Secondary outcomes

  1. Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months.

    Time frame: 6 months

  2. Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months.

    Time frame: 6 months

    AUA intermediate risk is PSA > 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b

  3. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30.

    Time frame: 6 months

  4. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS.

    Time frame: 6 months

  5. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog.

    Time frame: 6 months

  6. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue.

    Time frame: 6 months

  7. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F.

    Time frame: 6 months

  8. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 20, 2018
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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